Protocol Participant Support

Sources Sought Notice: HHS-NIH-NCI-SS-ETSB-0016-41 Title: Protocol Participant Support This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background: An important mandate of the National Cancer Institute (NCI) is to develop new treatments for cancer. In a highly integrative approach, the Lymphoid Malignancies Branch (LYMB) of the NCI's Center for Cancer Research (CCR) utilizes recombinant molecules produced by NCI's Biopharmaceutical Development Program and commercial agents as potential immune system modulators. The LYMB Clinical Trials Team coordinates several phase I/phase II clinical trials under protocols that have been approved by the NCI's Institutional Review Board (IRB) for the study of adult T-cell leukemia/lymphoma (ATL). The LYMB's current portfolio consists of the following protocols: - NCT01712659: "Phase I/II Trial Evaluating the Safety and Efficacy of Ruxolitinib in Patients with Smoldering or Chronic Adult T-Cell Leukemia (ATL)." - NCT02689453: "Subcutaneous Recombinant Human IL-15 (rhIL-15) and Alemtuzumab for People with Refractory or Relapsed Chronic and Acute Adult T-cell Leukemia (ATL)." - NCT00001582: "Collection of Blood, Bone Marrow, and Tissue Samples for Investigation of the Human Immune Response, Lymphoma Biology and HTLV-1 Infection." (Detailed information about each of the above listed trials is public information and can be accessed by visiting clinicaltrials.gov and searching by NCT number). Purpose/Requirements: The overarching goal of LYMB's clinical trials is to improve the understanding and treatment of ATL. ATL is a rare and highly aggressive lymphoproliferative disease that results from chronic infection with the retrovirus Human T-cell Lymphotropic Virus type 1 (HTLV-1). HTLV-1 is most pervasive in the Caribbean basin-specifically Jamaica-where the majority of ATL cases reside. Access to this population is crucial to the success of LYMB's study; therefore, LYMB requires a contractor with a strong presence in Jamaica that is capable of effectively identifying, diagnosing and referring ATL patients to LYMB's protocols. Scope: Identify, diagnose, refer and provide ongoing administrative support to current and prospective patients residing in Jamaica for new and existing ATL-related protocols. Requirements: Independently, and not as an agent of the Government, Contractor shall furnish all necessary labor, materials, supplies, equipment, needed to perform the following: Task 1. Refer Potential Study Participants. 1.1 Identify and interact with the target outpatient or inpatient population within Jamaica. 1.2 Diagnose ATL and screen for prospective study participants (residing in Jamaica) who meet the criteria specified by LYMB's various clinical trial protocols (listed above) and new trials as identified by LYMB staff. 1.3 Refer potentially eligible candidates (residing in Jamaica) and forward their medical records to the staff in LYMB, CCR, NCI. LYMB staff will decide on candidate eligibility after review of the records and inform the contractor whether the patient should initiate travel arrangements to come to the NCI for screening and possible enrollment. Task 2. Provide Ongoing Administrative Support. 2.1 Provide administrative support for the travel of patients (residing in Jamaica) selected for inclusion in NCI clinical trials. Contact LYMB's Patient Care Coordinator to coordinate participant (residing in Jamaica) travel to the National Institutes of Health's Clinical Center located in Bethesda, MD, United States. This support shall include, but is not limited to, coordinating travel arrangements with the LYMB Patient Care Coordinator, providing transportation schedules, and assisting patients with directions to and from the Clinical Center. 2.2 Provide administrative and financial support in obtaining valid documents required to enter the United States to participants (residing in Jamaica) selected to travel to the Clinical Center. This support includes, but is not limited to, submitting applications for passports and visas. (International travel and travel within the United States will be arranged and paid for by the Government). Anticipated period of performance: Base period of 12 months (11/1/2019 - 10/31/2020), with four (4) 12-month option periods. The intended procurement is classified under NAICS code is 541990 and the associated Small Business Standard is $15 million dollars. Qualified firms must also include the following information: a) Company Name. b) DUNS Number. c) Company point of contact, mailing address, telephone number, and website address. d) Name, Telephone number, and email address of a company point of contact who has the authority and knowledge to clarify responses with Government representatives. e) Date submitted f) If Applicable: GSA schedule number, or other available procurement vehicle. g) Do you have a Government approved accounting system? If so, please identify the agency that approved the system. h) Type of Company (i.e. small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM). i) All respondents must be registered and validated on SAM (https://www.sam.gov). Capability statement must show that the company can meet all the requirements listed under Purpose/Requirements must be submitted to the contact point at the email address given below. Capability statements will not be accepted after the due date. The maximum number of pages for submission is three (3) pages. All capability statements must be submitted in Adobe Portable Document Format (PDF). All responses must be received by the specified due date and time in order to be considered. All responses must be submitted electronically to Margo Katzper at mkatzper@mail.nih.gov by 3:00 PM Eastern on February 2/8/2019. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).